医院肠外营养解决方案的物理化学稳定性:组成和储存协议变化的影响
Luis Otero-Millán1,2, Brais Bea-Mascato3, Jose Luis Legido Soto4
1Pharmacy Department, University Hospital Complex of Vigo, 36312 Vigo, Spain.
Pharmaceutics
|May 25, 2024
概括
亲肠道营养 (PN) 溶液通常是稳定的. 然而,脂质和蛋白质度较低的PN显示出乳液不稳定性增加,这可能带来潜在的风险.
科学领域:
- 营养科学 营养科学
- 制药科学 制药科学
- 临床药房 临床药房
背景情况:
- 亲肠道营养 (PN) 在口腔或肠道途径不可行时,通过静脉输送营养素.
- PN溶液具有复杂的成分,增加了影响稳定性和患者安全的相互作用风险.
- 了解PN稳定性对于安全的临床应用至关重要.
研究的目的:
- 调查改变成分和储存条件对内营养 (PN) 溶液稳定性的影响.
- 在不同的储存协议下评估PN配方的物理稳定性.
主要方法:
- 用修改的成分度制备了23个PN样本.
- 样品在室温 (RT) 和4°C下保存了14天.
- 物理参数包括滴子直径,pH,密度和粘度定期测量.
主要成果:
- 脂质和蛋白质度降低的样本呈现出更大的液滴直径,表明潜在的乳液不稳定性.
- 在这些特定样本组的某些测量中观察到超出了美国药典 (USP) 的极限.
- 在测试条件下,pH,密度和粘度在很大程度上保持一致.
结论:
- 亲肠道营养溶液在评估条件下显示出临床使用的整体稳定性和安全性.
- 脂质和蛋白质度较低的配方表现出乳液不稳定性的倾向,需要仔细考虑.
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